Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06834672

Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-04-13

450

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multiregional, multicenter, randomized, open-label, phase III study to compare the efficacy, safety, and tolerability of IBI354 monotherapy with investigator's choice of chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan) in patients with HER2-expressing, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants with advanced ovarian, primary peritoneal, fallopian tube cancer who have failed or are intolerant to first-line or more platinum-based chemotherapy will be randomly assigned in a 2:1 ratio to two treatment arms: Experimental Arm: IBI354 monotherapy arm, 12 mg/kg IBI354 on Day 1 of each 3-week cycle; Control Arm: Investigator's choice chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan)

CONDITIONS

Official Title

Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 years or older
  • Ability to understand and provide written informed consent
  • Expected lifetime of 12 weeks or more
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer
  • Confirmed disease progression during or after the most recent anticancer therapy
  • At least one measurable target lesion according to RECIST v1.1 criteria
  • Left Ventricular Ejection Fraction (LVEF) of 50% or higher within 28 days before the first study drug dose
  • Adequate bone marrow and organ function
  • Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose and use effective contraception during treatment and for 6 months after
Not Eligible

You will not qualify if you...

  • Tumors with endometrioid, clear cell, mucinous, mesenchymal components, or low-grade/borderline tumors
  • Participation in other interventional clinical studies (except observational studies)
  • Prior use and progression on paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan
  • Recent treatments within specified timeframes including chemotherapy, immunotherapy, radiotherapy, surgery, strong CYP3A4 inhibitors/inducers, or live vaccines
  • Unresolved adverse reactions from previous anti-tumor therapy above Grade 1
  • Symptomatic central nervous system metastases or related conditions
  • Pneumonitis requiring corticosteroids or significant lung disease
  • Uncontrolled cardiovascular or cerebrovascular disease
  • Use of immunosuppressive medications within 14 days before first dose
  • Tumor invasion of important surrounding tissues or organs
  • Recent bleeding within 3 months before treatment
  • Symptomatic abdominal or pelvic effusion requiring intervention
  • Esophageal or gastric varices needing immediate intervention or high bleeding risk
  • Unhealed gastrointestinal obstruction, perforation, fistula, or risk thereof
  • Intraluminal stenting of digestive tract or trachea
  • Biliary obstruction
  • Hepatic encephalopathy, hepatorenal syndrome, or advanced cirrhosis
  • Significant malnutrition
  • Uncontrolled active infection
  • Other primary malignancies within 3 years or risk of recurrence
  • History of immunodeficiency or organ/bone marrow transplantation
  • Allergy to anti-HER2 antibodies, ADCs, or IBI354 components
  • Pregnancy, lactation, or plans to become pregnant
  • Other acute or chronic conditions increasing study risk or affecting results
  • Neurological, psychiatric, or social conditions affecting compliance or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China, 400044

Actively Recruiting

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Research Team

Y

Ya Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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